MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRAUMACEM(TM) V+ INJECTION CANNULA FOR TFNA - STERILE; DISPENSER, CEMENT

Model Number	10001851US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review has been requested.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2018, during an unknown procedure, after distal screw was placed into trochanteric femoral nail advanced (tfna), the cannula was stuck in the femoral head due to the cement setting.The tip of the cannula broke off in the helical blade.The traumacem cannula was left in the femoral head after cement was injected.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant devices: screw (part unknown, lot unknown, quantity 1).Helical blade (part unknown, lot unknown, quantity 1).This report is for one (1) traumacem(tm) v+ injection cannula for tfna - sterile.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history records review was completed for part: 03.702.121s, lot: arn185.Manufacturing location: selzach, release to warehouse date: feb 16, 2018, expiry date: dec 05, 2022.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Event: updated concomitant devices.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Concomitant devices reported: unknown screw (part#: unknown, lot#: unknown, quantity: 1), unknown helical blade (part#: unknown, lot#: unknown, quantity: 1), unknown cement (part#: unknown, lot#: unknown, quantity: 1).This is report 1 of 1 for (b)(4).

• Brand Name: TRAUMACEM(TM) V+ INJECTION CANNULA FOR TFNA - STERILE
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8121463
• Report Number: 2939274-2018-55215
• Device Sequence Number: 1630934
• Product Code: KIH
• UDI-Device Identifier: 04260277177874
• UDI-Public: (01)04260277177874
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2022
• Device Model Number: 10001851US
• Device Catalogue Number: 03.702.121S
• Device Lot Number: ARN185
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/26/2018; 12/26/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/03/2019; 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 76